Randomized controlled trial to compare the effects of single versus repeated intracoronary application of autologous bone marrow-derived mononuclear cells on total and SHFM-predicted mortality in patients with chronic post-infarction heart failure;REpetitive Progenitor cEll therapy in Advanced chronic hearT failure (REPEAT trial)

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

• Previous myocardial infarction at least 3 months ago, open infarct vessel or
bypass
• Left ventricular ejection fraction (LVEF) <= 45% on echocardiography
• Stable chronic heart failure NYHA class II to III under constant (4 weeks)
evidence-based optimal medical treatment
• age > 18 and expected to survive > 1 year
• written informed consent
• women of childbearing age: negative pregnancy test; effective contraception
for the first 8 months in the trial

Exclusion Criteria

• Non-ischemic cardiomyopathy
• Necessity for revascularization in other vessel than the infarct vessel at
the time of study therapy
• Hemodynamic relevant severe valvular disease with indication for operative /
interventional revision
• Heart failure with preserved ejection fraction (diastolic heart failure),
LVEF > 45%
• Unstable Angina
• Severe peripheral artery occlusive disease (>= Fontaine stadium III)
• Active infection (C-reactive protein > 10 mg/dl), any chronic
inflammatory disease
• Neoplastic disease without documented remission in the last 5 years
• Stroke <= 3 months
• Impaired renal function (Serum creatinine > 2,5 mg/dl) at the time of
study inclusion
• Relevant liver disease (GOT > 2x upper normal limit, spontaneous INR >
1,5).
• Diseases of hematopoetic system, anemia (Hemoglobin < 8.5 mg/dl),
thrombocytopenia < 100.000/µl)
• Splenomegaly
• Allergy or intolerance of clopidogrel, prasugrel, ticagrelor, heparin,
bivalirudin
• History of bleeding disorder
• gastrointestinal bleeding <= 3 months
• major surgery or trauma <= 3 months
• Uncontrolled hypertension
• Pregnancy, lactation period
• mental retardation
• previous cardiac cell therapy within last 12 months
• Participation in another clinical trial <= 30 days

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>2-year total mortality is significantly lower in patients receiving 2 repeated<br /><br>intracoronary applications of autologous bone marrow-derived progenitor cells<br /><br>(t2c001) compared to patients receiving 1 intracoronary application of<br /><br>autologous bone marrow-derived progenitor cells (t2c001).</p><br>

Secondary Outcome Measures